This application claims benefit of U.S. Provisional Application No. 60/542,070, filed Feb. 5, 2004, which is hereby incorporated by reference.
The present invention relates to a composition and method for preventing and treating allergic reactions and diseases.
Many individuals are affected by allergy-related immunological disorders. Such disorders include, for example, bronchial asthma, allergic rhinitis (hay fever), and atopic dermatitis. Although these disorders have somewhat different effects on the body, they share a common allergic response, referred to as a type I, or immediate-type, anaphylactic allergic reaction. This response is mediated by substances, such as immunoglobin E (IgE) and histamines, and includes several steps.
In the first step of the reaction, referred to as the sensitization step, an immune response to an allergen is initiated upon exposure of a responsive individual to the allergen. This results in the generation of B cells that secrete allergen specific IgE. The IgE subsequently binds to IgE receptor sites on mast cells and basophils. In a second step, referred to as the degranulation step, when re-exposed to the allergen, the aforementioned receptor-bound IgE binds to the allergen resulting in degranulation of the mast cells and basophils. Degranulation releases a variety of vasoactive mediators, for example, histamines and proteases, which subsequently promote allergic and inflammatory responses. The third step, referred to as the inflammation step, is triggered by the mediators, and causes inflammatory cells to a) accumulate at sites of inflammation, for example, target organs, such as the lungs, and b) release chemicals, such as interleukin-3, interleukin-6, and macrophage colony stimulating factors. While inflammatory cells are normally activated to provide tissue defense, tissue maintenance and immunoregulation, in the case of allergies, activation of inflammatory cells serves to augment the allergic response.
Several allergic disease treatments exist. Many of these treatments use steroids to either inhibit the release of substances during the degranulation step, or inhibit the allergic reactions induced during the inflammation step. Although effective in mitigating allergic responses, these treatments are unhelpful in preventing the onset of the type I allergic reaction, that is, the treatments fail to inhibit IgE production, and accordingly fail to stop the underlying inflammatory process. A consequence of this is that the treatments also fail to prevent an often life-threatening reaction referred to as anaphylactic shock, which is triggered simply by the initiation of the type I allergic reaction. Further, many of drugs used to inhibit the degranulation and inflammation steps also have undesirable side effects. For example, degranulation is often treated with corticosteroids, and inflammation is frequently treated with glucocortosteroids; however, these drugs can cause numerous side effects, such as weight gain, water retention, hypertension, and increased cholesterol levels.